Good morning, Mr. Chair and honourable members. Thank you for the opportunity to testify before this committee.
My name is Marian Stanley. I'm a chemist by training. I'm a senior director at the American Chemistry Council and I've managed the Phthalate Esters Panel, which is a part of that council, for the last 17 years.
The panel represents the major producers of phthalate esters in the United States and North America. Since its inception in 1973, the panel has demonstrated its commitment to the safe use of its products by sponsoring health, safety, and environmental research.
The panel strongly supports the regulation of chemicals based on sound science. Phthalates are among the most well-studied chemicals on the planet and they have been the subject of hundreds of studies in laboratory animals and numerous government-sponsored assessments in Canada, the U.S., the EU, and Japan. These assessments have studied the risks to human health posed by exposure to phthalates.
The phthalate panel firmly believes the weight of scientific evidence demonstrates that the ban on phthalates proposed in Bill C-307 is unnecessary to protect human health. Bill C-307 proposes to ban butyl benzyl phthalate, dibutyl phthalate, and di(2-ethylhexyl) phthalate in products for use by a child in learning or play and in products that are put in the mouth of an infant when used. At the outset, the proposed ban of these three phthlates in children's toys would do little to protect children's health.
Butyl benzyl phthalate is most commonly used in flooring and insulating sealants. Dibutyl phthalate is used primarily in adhesives as a solvent for organic compounds and in nail polish. These are cellulosic plastics, not vinyl. Another way to think of this, think of screwdriver handles: they are also plasticized by dibutyl phthalate, a cellulosic plastic.
DEHP is used primarily in medical devices, as Dr. Cammack described, and in some soft plastic toys, as Ms. Axmith talked about—swim wings, plastic waterslides, but also in things like raincoats, backpacks, flip-flops, and other products children use in their daily life. These are not intended to be placed in the mouth by children and are safe as they're currently used.
In addition, numerous government risk assessments of these three phthalates have demonstrated that exposure to phthalates in toys and children's products generally poses no significant risk to children. Both the U.S. national toxicology program, the Center for the Evaluation of Risks to Human Reproduction, as Dr. Cammack described, and the European Union have performed risk assessments of these three phthalates proposed to be banned by Bill C-307, and these agencies have found no significant risk to children from exposure to these phthalates.
Similar to its being banned in toys, the proposed ban on DEHP in cosmetics would be of little benefit to human health because DEHP is not used in cosmetics. DEHP is a vinyl plasticizer, and, generally, what I put on my face isn't vinyl. As for dibutyl phthalate, exposure levels to dibutyl phthalate from nail polish are extremely low, such that the risks from exposure to DBP are minimal. For example, dibutyl phthalate exposure levels for the thousands of study participants derived from the U.S. Centers for Disease Control and Prevention biomonitoring data show that levels of exposure to dibutyl phthalate are well within the safety limits set by the U.S. Environmental Protection Agency. These levels already incorporate a number of conservative safety margins. Because the animal data is reviewed, the no-effect level is then assessed, and the “up to 10,000 factor of safety” level is already applied, you've got a built-in precautionary system at work in North American regulatory agencies today.
I'd like to make two points. The measured exposures to dibutyl phthalate and the other phthalates are lower than previous estimates. Additionally, for dibutyl phthalate, the EPA has rereviewed the toxicology data and raised the safety factor for dibutyl phthalate threefold. In effect, that means that a woman using nail polish with dibutyl phthalate would have to use five bottles a day and absorb every single molecule of dibutyl phthalate to reach a level that caused no effect in rodents.
The U.S. Food and Drug Administration, which has regulatory authority over cosmetics, studied the CDC's biomonitoring data in 2001 and said it found no reason for consumers to be alarmed at the use of cosmetics containing phthalates. The FDA continues to evaluate available data on phthalates in cosmetics and has not seen any data that led it to take further steps. Moreover, an extensive 2002 review by the cosmetic ingredient review expert panel--this is an FDA-sanctioned independent body of toxicologists and dermatologists that regularly reviews all compounds used in cosmetics and personal care products--found that dibutyl phthalate and other phthalates used in cosmetics were safe as currently used.
Finally, the 2006 EU risk assessment of dibutyl phthalate mentioned above specifically found no concern for consumers using nail polish containing dibutyl phthalate.
The deck that you all have has a page on DEHP in medical devices. I won't go over that, since Dr. Cammack covered it so very thoroughly, but there are some highlights there for you to read at your leisure. On page seven in the deck that I've given you is a table that summarizes the reviews of the three phthalates that are included in Bill C-307. It looks at the reviews that were conducted in Canada, the European Union, and the United States. So this would be a very quick resource for you.
I'd like to conclude by saying that the extensive science shows that bans proposed in Bill C-307 are unnecessary to protect human health. The government-sponsored risk assessments in North America, Japan, and Europe have demonstrated that human exposure to phthalates in consumer products, including toys and cosmetics, is well below any level that has been shown to cause adverse health effects in laboratory animals, and they are well below government-established safety levels.
Consequently, the effect of these bans on phthalates proposed in Bill C-307 would be to place a significant burden on both manufacturers and retailers of phthalate-containing products and on the consumer and medical patients who rely on the performance and convenience made with phthalates, while it would provide no measurable benefits to human health. For this reason, the phthalate esters panel opposes Bill C-307.
Thank you for your time.